The Effect of a Novel Dual-Task Exercise Program for Balance, Mobility and Cognition in Community Dwelling Older Adults

This study is not yet open for participant recruitment.
Verified December 2013 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01940055
First received: September 6, 2013
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

Goal:

The development of a Treadmill Rehabilitation Platform (TRP) for task-orientated rehabilitation that provides an adapted, blended approach among older adults with balance, mobility, and cognitive impairments.

Study Objective:

Examine the feasibility and benefits of a novel dual-task intervention to address mobility and cognitive decline with age using engaging interactive video games during treadmill walking and recumbent cycling.This will include evaluation of the effects of two interventions, one using treadmill walking and the second a recumbent cycle ergometer on

  1. Core balance
  2. Cardiac fitness, exercise endurance
  3. Gaze control
  4. Gait performance measure (walking stability and spatial-temporal gait parameters)
  5. Specific executive cognitive function (processing speed, cognitive inhibition, working memory)
  6. Dual task function during treadmill walking

Hypothesis:

  1. Dual-task exercise program will improve core balance and walking function to a greater extent in the Treadmill walking group compared to recumbent cycle group.
  2. Executive function will improve equally in both the treadmill walking and recumbent cycle group.
  3. Dual task exercise programs will have significant effect on gaze stability and cardiac fitness equally for both the treadmill and recumbent cycling groups.

Condition Intervention Phase
Aging and Fall Risk
Behavioral: Dual task treadmill walking exercise program
Behavioral: Dual task recumbent cycling exercise program
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Pilot-Randomized Clinical Trial to Study the Effect of a Novel Dual-Task Exercise Program for Balance, Mobility and Cognition in Community Dwelling Older Adults

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Dual task function during walking [ Time Frame: Pre and post intervention of 10 weeks ] [ Designated as safety issue: No ]
    Walking on at treadmill at a speed of 0.9 m/s while performing a cognitive game task simultaneously i.e the participants move a paddle (game sprite to catch bright circle objects(targets)moving vertically top to bottom, avoiding other shape(or colors) game objects (dis-tractors). This test game provides an objective quantification of cognitive functions like (i) Game success rate (percentage of target caught), (ii) average motor response time (time from appearance of the target to start of the paddle movement), (iii) average movement execution time (iv) movement efficiency .

  • Executive function [ Time Frame: Pre and post intervention of 10 weeks ] [ Designated as safety issue: No ]
    Participants will be asked to perform a few neuropsychological tests like the Trail making test (A and B), Verbal Fluency, Visual Search and the dimensional change card sort test

  • Core Balance [ Time Frame: Pre and post intervention of 10 weeks ] [ Designated as safety issue: No ]
    I t will be measured by performing a) Clinical Test of Sensory Integration of Balance and b) Five - Time Sit-to-Stand Test

  • Spatial - temporal gait variables [ Time Frame: Pre and post intervention of 10 weeks ] [ Designated as safety issue: No ]
    It will be measured by asking the participants to walk on a treadmill for 2 minutes which is instrumented with a pressure mat at a speed of 0.9 m/s. Average and coefficient of variation will be obtained for the following parameters: swing time, step time, step length and step width.

  • Cardiac fitness [ Time Frame: Pre and post Intervention of 10 weeks ] [ Designated as safety issue: No ]
    Cycle ergometer Submaximal Test will be performed measuring the heart rate, blood pressure, revolution per minute and rate of perceived exertion at an interval of 5 minutes.


Secondary Outcome Measures:
  • 6- Minute walk test [ Time Frame: Pre and post intervention of 10 weks ] [ Designated as safety issue: No ]
  • CHAMPS Questionnaire [ Time Frame: Post intervention of 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental group
Dual Task Treadmill Walking Exercise Program
Behavioral: Dual task treadmill walking exercise program
Participants will receive 5 minute warm up and cool down session followed by a 30 minute dual task program which includes treadmill walking while playing brain fitness or cognitive games. Rest periods will be provides to the participants. Treadmill speed will be set so as to not exceed 60% of maximum heart rate. Heart rate and perceived excretion( per the Borg 1-10) will be measured at 5 minutes of interval.
Active Comparator: Control group
Dual task recumbent cycling exercise program
Behavioral: Dual task recumbent cycling exercise program
Participants will receive a 5 minute warm up and cool down session followed by a 30 minute dual task exercise program which includes recumbent cycling while playing brain fitness or cognitive games. Rest periods will be provides to the participants. Recumbent cycling speed will be set so as to achieve 60% of maximum heart rate. Heart rate and perceived excretion( per the Borg 1-10) will be measured at 5 minutes of interval.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   70 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Age between 70-80 years old.
  2. Independent community dwelling
  3. Walk 400 meters without a walking aid or using a single-point stick only.
  4. Mini mental status test score greater than 24
  5. Experiencing no more than one fall in the previous 12 months.
  6. Having concerns about their balance which is based on participants' positive response to the question: "Are you concerned about your balance?"
  7. Adequate hearing and vision

Exclusion Criteria:

  1. Clinical diagnosis of dementia and a Mini Mental State Exam score less than 24,
  2. Self-reported diagnosis or history of (i) stroke, traumatic brain injury or other neurological disorders such as Parkinson's disease and Vestibular disorders, (ii) cardiac disease, and (iii) muscular-skeletal injuries or orthopaedic diseases such as acute lower back or lower extremity pain, peripheral neuropathy, advanced hip/knee osteoporosis.
  3. Any recent medical illness that would affect their balance or ability to walk for a period of at least 6 minutes.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01940055

Contacts
Contact: Tony Szturm, PT,PhD 204-787-4794 tony.szturm@med.umanitoba.ca
Contact: Akshata Nayak, MSc Student 204-806-0719 aksnayak_21@yahoo.com

Locations
Canada, Manitoba
Reh Fit Center Not yet recruiting
Winnipeg, Manitoba, Canada, R3M 3V8
Contact: Darlene Lamont    (204) 488-8023      
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Akshata V Nayak, MSc Student University of Manitoba
Principal Investigator: Tony Szturm, PT,PhD University of Manitoba
Principal Investigator: Rehab Alhasani, MSc Student University of Manitoba
Principal Investigator: Geri Brousseau, PhD University of Manitoba